Genetic Engineering & Biotechnology News

SEP15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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22 | SEPTEMBER 15, 2017 | GENengnews.com | Genetic Engineering & Biotechnology News There have been very few projected models of best practice for end-to-end (i.e., truly or fully) continuous biomanufacturing. Based on some of the patents filed and/or granted for a totally continuous model, a notable difference be- tween models is the use of a surge tank between upstream and downstream operations. Some experts argue if you are using a surge tank, the model isn't really continuous, while others ar- gue the benefit of using these tanks, asserting they add safety to the process stream. Below are some expert perspectives on the matter. GEN How do surge tanks add safety to a fully continuous manufacturing line? Gerben Zijlstra (Sartorius Stedim Biotech): Basically, surge tanks allow short stops of the following unit operation, without the need for stopping or even terminating the entire process. These short stops may enable short maintenance activities, to resolve failure modes (e.g., exchanging blocked filters, ex- changing pump tubing, exchanging reduced capacity resin), thereby substantially mitigat- ing the risk of premature process termina- tion, by small incidental failures. Michelle Najera (CMC Biologics): In an ideal case, all steps in a continuous manufactur- ing line process would operate at the same pace so that there is uninterrupted flow be- tween steps. However, without surge tanks, the entire processing line would need to slow down or stop altogether if there was a pause or slow down for a single step. Surge tanks between each step increase the flexibility and robustness of a continuous manufac- turing line by providing a temporal cushion between the linked steps. Additionally, a surge tank is often needed to maintain rela- tively low operating pressures. If all unit op- erations are connected without a break, the pressure rating for the upstream operations would likely be higher than equipment typi- cally used in biomanufacturing. Gerard Gach (LEWA): [Surge tanks] would al- low for individual unit operations to adjust CORe ™ M ini Biore actor POWER FOR DISCOVERY Culture Optimization Reactor system designed with the capabilities of a larger system but a t a much lower c ost a nd smaller f ootprint • Flexible, single-use vessel design is free of interfering inserts and probes • O perational control driven through o n-board software interface • Bioreactor pump customization options allow high level of experimental control and flexibility • Id e a l for stem cell re se a rc h a nd d e ve lo pment, cell and tissue culture , seed development, educational applications and more • Supports batch, fed batch and c o n t in u o u s b io p ro c e ss a p p lic a t io n s wit h addition of a cell separation d e vic e Get all the details at BPI East in Boston, or contact us to arrange a demo or trial at info@refinetech.com Also visit www.refinetech.com , or call (973) 952-0002, Ext 302. Experts Discuss Inclusion of a Surge Tank in an End-to-End Continuous Biomanufacturing Train To Surge or Not to Surge? Bioprocessing Perspectives OXY-1 - The compact USB- Oxygen Meter Software Measurement Studio 2 included Scan QR code for more information:

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